Medical Device Recalls

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

Aesculap Implant Systems LLC

BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and

Becton Dickinson & Co.

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p

Remote Diagnostic Technologies Ltd.

Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Mode

Stryker Medical Division of Stryker Corporation

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo

DRG International, Inc.

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L

B Braun Medical Inc

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommen

ev3 Inc.

MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672

MEDLINE INDUSTRIES, LP - Northfield

HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup

Hamilton Medical, Inc.

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Philips North America

Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation d

Deerfield Imaging, Inc.

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP

Covidien LP

BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin

CareFusion 303, Inc.

Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar ene

Boston Scientific Corporation

Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac

Integra LifeSciences Corp.

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

Medline Industries, LP

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

Bio-Rad Laboratories

GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonanc

GE Healthcare, LLC

Impella RP Flex with SmartAssist. Product Code: 1000323.

Abiomed, Inc.

Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L RED Model/Catalog Number: 91878 Product Description: NON-Sterile

Jiangsu Shenli Medical Production Co., Ltd.

Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,

Masimo Corporation

One Step K in vitro diagnostic test REF: 81A4

DFI Co., Ltd.

Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Gentueri Inc

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1

Intuitive Surgical, Inc.

17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-O

DRG International, Inc.

Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte

Abiomed, Inc.

Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single us

Shent USA, Inc.

IntelliVue Patient Monitor MX800. Product Number: 865240.

Philips North America Llc

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150

Mentor Texas, LP.

Spectral CT. Computed tomography X-ray system.

Philips North America Llc